Back to resultsEvaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Moderate Acne Vulgaris, Acne
Eligibility Criteria
Inclusion Criteria:
- Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (<5mm) on the face).
Exclusion Criteria:
- Standard contraindications for use of combined oral contraceptives (class label)plus
- Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
- Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical peelings, mechanical extraction of comedones)
- Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful
- Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.
Secondary Outcome Measures
Change from baseline in count of papules
Change from baseline in count of pustules
Change from baseline in count of nodules
Change from baseline in count of open comedones
Change from baseline in count of closed comedones
Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00656981
Brief Title
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
Official Title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety & Efficacy of Oral Contraceptive Prep., Containing Drospirenone 3 mg/Ethinyl Estradiol 20 Mcg for 6 Treatment Cycles in Women With Moderate Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
5. Study Description
Brief Summary
The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Moderate Acne Vulgaris, Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
541 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Intervention Description
The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Primary Outcome Measure Information:
Title
Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.
Time Frame
From baseline to Cycle 6.
Secondary Outcome Measure Information:
Title
Change from baseline in count of papules
Time Frame
Visits 3-5
Title
Change from baseline in count of pustules
Time Frame
Visits 3-5
Title
Change from baseline in count of nodules
Time Frame
Visits 3-5
Title
Change from baseline in count of open comedones
Time Frame
Visits 3-5
Title
Change from baseline in count of closed comedones
Time Frame
Visits 3-5
Title
Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
Time Frame
Visits 3-5
Title
Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
Time Frame
Visits 3-5
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (<5mm) on the face).
Exclusion Criteria:
Standard contraindications for use of combined oral contraceptives (class label)plus
Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical peelings, mechanical extraction of comedones)
Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful
Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Kingman
State/Province
Arizona
ZIP/Postal Code
86401
Country
United States
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80108
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Shawnee
State/Province
Kansas
ZIP/Postal Code
66203
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
East Steauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223-6683
Country
United States
City
Byran
State/Province
Texas
ZIP/Postal Code
77801
Country
United States
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
We'll reach out to this number within 24 hrs